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POLYTRIM

NDA

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | N050567 | ALLERGAN INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Polytrim (2023)

Total Spending

$937.52

Total Claims

Beneficiaries

Avg Cost/Unit

$6.70

Spending Trend

$17K(2019)→$10K(2020)→$7K(2021)→$4K(2022)→$937.52(2023)

YoY Change:+6.9%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 5, 2025	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 20, 1988

No patent or exclusivity listings for this strength.